Remote PVRM Safety Lead – Senior Pharmacovigilance Scientist

Sumitomo Pharma; Madison (WI); Remote; USD 157,000 - 196,000; Full time

Job summary

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. You will guide cross‑functional teams in safety governance, adverse event assessment, and regulatory responses to ensure patient safety and data integrity.

This is a primarily remote position with periodic on‑site meetings. Requirements include 6+ years in pharmacovigilance, strong signal detection and analysis, and a bachelor’s degree in life sciences;

Qualifications

• Bachelor’s degree in healthcare, life sciences, or related field.
• 6+ years of relevant pharmacovigilance, drug safety, or related pharma/biotech industry experience.
• Experience with FDA/EMA pharmacovigilance requirements and GCP/GVP guidelines.

Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance to key documents.
• Contribute to signal detection, monitoring, evaluation, and communication of safety information.
• Maintain ongoing monitoring and assessment of safety profiles for assigned products; support benefit-risk evaluation.
• Review adverse event reports and relevant clinical coding to support safety assessments.
• Coordinate responses to regulatory authorities and lead safety-related documentation.

Skills

Pharmacovigilance

Drug safety

Signal detection

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Sumitomo Pharma America seeks a Senior Manager, Pharmacovigilance Scientist to lead safety evaluation and risk management for assigned programs. You will guide cross‑functional teams in safety governance, adverse event assessment, and regulatory responses to ensure patient safety and data integrity.

This is a primarily remote position with periodic on‑site meetings. Requirements include 6+ years in pharmacovigilance, strong signal detection and analysis, and a bachelor’s degree in life sciences;